Health groups: Defend affordable drug treatment in India

Bayer sues Indian Government to retain monopoly rights / International coalition demands protection of generic pharmaceuticals

Health groups call on German drugmaker Bayer to cancel the suit against the Indian government and domestic drug company Cipla in order to protect affordable drug treatment. The organizations fear that the fate of generics in India may hinge on this case and that thousands of Indians will die without affordable pharmaceuticals.

Last year Bayer sued the Indian government in the Delhi High Court for giving marketing approval to Cipla for Bayer's patented cancer drug Sorafenib. At present, the Indian drug regulator DCGI can give a marketing approval to a generic drug even if the medicine is patented in India. Public health experts point out that marketing approval for a drug is not an infringement of a patent, and the generic company can be challenged once it launches the drug.

Amit Sen Gupta from the Indian Peoples Health Movement says: “The Bayer case has implications for drug access, not just for patients in India, but for poor people in large parts of the world. It would mean giving sanctity to higher standards of patent protection than what is required even by the TRIPS agreement. Bayer not only seeks to safeguard its own monopoly right, the company also wants to set a precedent that other corporations can benefit from. In essence it would mean that the entry of generic versions of life saving drugs would be delayed.

Philipp Mimkes from the Coalition against Bayer Dangers, an international network based in Germany, adds: “The interest of patients is at risk if marketing approvals are linked with patents. Countries like India must have the possibility to issue compulsory licenses to generic companies or to impose price controls in order to make available affordable drugs. We demand that Bayer quits this suit! Safeguarding public health must take precedence over patents and monopoly profits of drug companies!

The case seeks to link the patent status of a drug with the procedures related to the drugs marketing approval. Across the globe, such linkage is the exception rather than the rule. That is so because the body responsible for granting patent applications is distinct from the one that grants approval for marketing. To ask drug regulators to do the job of the Patent office is incorrect because they don´t have the expertise to decide on patent related issues.

The Indian law has a provision for post-grant opposition, i.e. the grant of a patent can be challenged on several grounds after it is granted. A blanket bar on granting marketing approval to drugs which have been granted patents would mean that this provision becomes ineffective– the generic company would not be able to make use of this provision immediately even if a patent grant is overturned.

Moreover, both the TRIPS agreement and the Indian law allow medicines to be legally registered even when the drug is under patent protection. It can be allowed so that the generic version of the medicine can be made immediately available as soon as the patent term of a medicine expires or as soon as a compulsory license is issued to a generic company. It can also be allowed in situations where the medicine is used for research purposes. This provision is an important health safeguard because it allows generic manufacturers to conduct tests on its generic version, so that it is ready for marketing as soon as it is legally possible. In the case of life saving drugs, even a delay of a few months in the introduction of cheaper generics can mean hundreds or thousands of deaths among patients who would die, not because there is no treatment, but because the treatment with a patented medicine is too expensive.

If Bayers plea is upheld, it would be in violation of the Indian Patent Act. This would be extremely unfortunate, as it would mean overturning some of the health safeguards that the Indian Parliament had put in place when the Indian Act was amended in 2005 to make it TRIPS compliant. It may be recalled that the Indian Parliament, while putting in place these safeguards had taken into account the very large mobilisation of people – in India as well as across the globe - demanding that India continue to function as a source for affordable generic medicines.

Fate of generics hinges on Bayer case

The fate of generic pharma industry and particularly accessibility of medicines will be decided when multinational Bayer's case against the government comes up for hearing in the Delhi High Court
on Monday.

Bayer has taken the Union government and its drug controller to court, indirectly seeking patent linkages linking regulatory approval of generic medicines with their patent status. In other words, patent linkages mean that no marketing approval is given for generic versions of medicines, which have been granted a patent in India.

This is one of rare instances an MNC suing the Indian government to introduce higher intellectual property standards, than what is required under Trips agreement (trade-related aspects of intellectual property rights), experts say.

Since the government has been made a respondent in Bayer's petition, generic industry has asked ministry of health to defend before the court about the decision of not implementing a Trips-plus provision like patent linkages in India.
The Indian Pharmaceutical Alliance has asked the health ministry to ensure that registration of generic drugs does not get affected with their patent status.

The grounds of Bayer's petition are that the drug controller entertained Cipla's application for grant of marketing rights to generic version of its anti-cancer drug, 'Nexavar', for which it has obtained a patent in India. If marketing approval were granted, its patent rights would be affected, it says.

The case has a huge impact on accessibility of medicine and generic production in general as it may encourage patent holders to approach courts to prevent or delay marketing approval of affordable versions of patented drugs.

Bayer had earlier requested the drug controller to reject Cipla's application, as well as grant a hearing to the company before taking any decision on the matter. But this was not done, it adds.

The court in its interim order in November directed the drug controller from taking any decision on Cipla's application.

By seeking rejection of Cipla's application, the MNC wants to link marketing approval to the drug's patent status, which has potential to cause serious harm, experts say.

This is because patent linkages create barriers to the use of compulsory licenses, which are issued to generic producers if patented drugs are not available or affordable, or if countries that lack production capacity order drugs from countries like India.

Linking patent status and registration of medicines means that the drug regulatory authority is required to withhold marketing approval to a generic version of a patented drug regardless of whether the patent granted is valid or not, they added.

Moreover, public health experts point out that marketing approval for a drug is not an infringement of a patent, and the generic company can be challenged once it launches the drug, not at the stage of applying for registration.

During last year multinational pharmaceutical companies lobbied with the drug controller to reject marketing approval to generic companies on patented drugs. Any approval of generic versions of patented drugs would according to them be in violation of their patent rights and would lead to increased litigation.

Proposals to link registration of drugs with their patent status are not new and have been promoted by MNCs and their associations. Several developing countries have faced pressure to introduce patent linkages. In 2001, a group of companies took the South African government to court to prevent it from importing cheaper AIDS medicines, and more recently, Pfizer sued the Philippine government.

Jan 17, 2009, Economic Times

No antidote to stop copies of patented drugs: Health min

The health ministry has said it is not equipped with technical expertise to stop domestic pharmaceutical companies from copying patented drugs. The Delhi High Court (HC), in its interim order on December 19, 2008, told the Drug Controller General of India (DCGI) not to allow companies to market generic versions of medicines patented in India. Multinational drug manufacturers Bayer AG and Bristol-Myers Squibb had approached the court against violations of their patent rights.

"The office of the drug quality regulator DCGI is not equipped to assess patentability of drugs. It can only caution generic drugmakers. But we cannot deny marketing approvals," an official in the health ministry, who didn't wish to be named, said. He said the regulator did not have the mandate to investigate patent violations. Indian generic drugmakers say that the DCGI's role is limited to regulating safety and efficacy of medicines and not to look into violation of patent rights that have commercial implications.

India, which is a signatory of the trade-related intellectual property rights (TRIPS), is committed to provide patent protection for 20 years. According to the agreement, a drugmaker cannot market the generic equivalent of a patented drug before the 20-year window period. There are cases where drugmakers have got approvals for selling generic versions of patented medicines, the official said. Such generic drug makers could be penalised if the original drug manufacturers patent violation is proved in the court, he added.

Multinational drugmakers, who launch new generation drugs after getting 20-years exclusive marketing rights, criticise the government for practicing double standards.

"While one arm of the government (patent office) grants patents, the other arm (DCGI) takes them back by giving marketing licenses to generic drugmakers," an executive of a multinational pharmaceutical company, who wished not to be named, said.

The controversy started after Indian company Cipla launched its low cost versions of Swiss drugmaker Roche's patented drug Tarceva in India last year. Although the matter is awaiting the final verdict of the court, Cipla has been allowed to sell its drugs in public interest as the drug cost one-third of Roche's medicine. But Cipla will have to pay damages if the ruling goes in Roche's favour.

Daily Mirror (Sri Lanka), February 09, 2009

Patents a pill to kill patients

We celebrated our 61st Independence Day last Wednesday. Our people can enjoy true independence only if they have economic independence and economic growth. And economic growth is critically dependent on regular access to affordable healthcare and essential medicines. Sri Lanka and other developing countries have been campaigning for international trade agreements that will exclude medicines from patent protection. The campaign was to promote generics which are much cheaper than brand name drugs.
The developed countries have now joined developing countries in saying “no to patents and to brand name drugs, promoting generic drugs and are looking to the generic drug industry as a saviour.
The Japanese finance minister, in November last year issued a report complaining that the countrys use of generics was less than a third of that in America or Britain. Canadas competition watch dog criticized the countrys pharmacies for failing to pass on the savings made possible by the use of generics. That greed, it was estimated, cost the Canadian tax payer US$ 800 million a year. As reported in the Editorial, Daily Mirror on 21st January, the proposed healthcare reform in the US would make tough decisions to reduce or deny payment for new drugs and procedures that are not as effective as the existing old and established ones. The reform will also include prescribing low priced generics and not the more expensive brand name drugs.
One the other hand events in India give rise to concerns. Health groups in Asia and Germany call on German drug maker Bayer to cancel the suit against the Indian government and the Indian generic manufacturer Cipla in order to protect affordable drug treatment. Last year Bayer sued the Indian government in the Delhi High Court for giving marketing approval to Cipla for Bayer's patented cancer drug Sorafenib.
Amit Sen Gupta from the Indian Peoples Health Movement says: “The Bayer case has implications for drug access, not only for patients in India, but for poor people in large parts of the world. It would mean giving sanctity to higher standards of patent protection than what is required even by the TRIPS agreement. Bayer not only seeks to safeguard its own monopoly right, the company also wants to set a precedent that other corporations can benefit from. In essence it would mean that the entry of generic versions of life saving drugs would be delayed.
The governments in both the developed and developing countries are calling for the promotion of generics. However the multinational drug industry is using the courts to prevent the manufacture of generics. In this context, Sri Lanka has scored a first with generic promotion as a public policy. The Sri Lanka National Medicinal Drug Policy (NMDP) was adopted by parliament in 2006. One of the components of the NMDP is the enactment and implementation of legislation requiring generic prescribing and allowing cost effective generic substitution with the consent of the patient (and where possible inform the doctor). There has been opposition by vested interests leading to the non-implementation of the NMDP up till now. PMRP urges the Minister of Health to implement it soon ignoring the opposition from vested interests and make good quality essential drugs to all at affordable prices.